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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC. ORTHOPEDIC TRAY

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MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC. ORTHOPEDIC TRAY Back to Search Results
Model Number DYNJ04385U
Device Problem Microbial Contamination of Device (2303)
Patient Problem Insufficient Information (4580)
Event Date 10/26/2020
Event Type  Malfunction  
Event Description

Concern that mold was found in the creases of the table pack drape.

 
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Brand NameMEDLINE INDUSTRIES, INC.
Type of DeviceORTHOPEDIC TRAY
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
one medline pl.
mundelein IL 60060
MDR Report Key11541708
MDR Text Key241428584
Report Number11541708
Device Sequence Number1
Product Code OJH
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 03/12/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/22/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberDYNJ04385U
Device Catalogue NumberDYNJ04385U
Device LOT Number20EKB413
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/12/2021
Event Location Hospital
Date Report TO Manufacturer03/22/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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